40 CFR 172.48 - Data requirements for a notification.

This section identifies the data and information to be included in each Notification. When specific information is not submitted, an explanation of why it is not practical or necessary to provide the information is to be provided.

(a) The identity of the microorganism which constitutes the microbial pesticide including:

(1) Summary of data supporting the taxonomic designation and its interpretation.

(2) Means and limit of detection using sensitive and specific methods (e.g., note the use of any markers that are used to distinguish the introduced population from native microorganisms). Introduction into the microbial pesticide of a unique genetic marker is encouraged.

(b) Description of the natural habitat of the parental strain of the microbial pesticide including information on:

(1) Physical and chemical features important to growth and survival of the parental strain.

(2) Biological features of the parental strain that would have an impact on the microbial pesticide (e.g., presence of phages that infect the microorganism).

(3) Competitors.

(c) Information on the host range of the microbial pesticide, if any, with an assessment of infectivity and pathogenicity to nontarget organisms.

(d) Information on survival and the ability of the microbial pesticide to increase in numbers (biomass) in the environment (e.g., in the environment into which the microbial pesticide will be introduced, and in substantially different environments that may be in the immediate vicinity). These data may be derived from the scientific literature or from tests conducted in a laboratory or other containment facility.

(e) The identity of possible transmission vectors (e.g., insects).

(f) Data on relative environmental competitiveness compared to the parental strain of the microbial pesticide.

(g) Description of the methods used to genetically modify the microbial pesticide.

(h) The identity and location of the gene segments that have been rearranged or inserted/deleted (host source, nature, and, for example, base sequence data, or restriction enzyme map of the genes).

(i) Information on the control region of the genes, and a description of the new traits or characteristics that are expressed.

(j) Data on potential for genetic transfer and exchange with other organisms and on genetic stability of any inserted sequences in the microbial pesticide.